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Report for Clinical Trial NCT04034446
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      This is a single arm, open-label, single center study to determine the safety and efficacy of
      CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
    
Name: CD19-CD22 CAR-T cells
Description: 0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.
 Type: Biological
  
Primary Outcomes 
 Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: 24 months
 Measure: Overall remission rate (ORR) Time: 3 months
   
Secondary Outcomes 
 Measure: Response at Day 28 days Time: 1 month
 Measure: Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment. Time: 6 months
 Measure: Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow Time: 6 months
 Measure: Relapse-free survival (RFS) Time: 24 months
 Measure: Duration of remission (DOR) Time: 24 months
 Measure: Overall survival (OS) Time: 24 months
 
Purpose: Treatment
Allocation: N/A
Single Group Assignment 
There is one SNP
SNPs
1 T315I 
5. Without remission or relapse after any prior CD19 targeted therapy;
          6. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
             intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no
             TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation
             Thr315Ile (T315I) mutation. --- Thr315Ile --- 
5. Without remission or relapse after any prior CD19 targeted therapy;
          6. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are
             intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no
             TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation
             Thr315Ile (T315I) mutation. --- Thr315Ile ---  --- T315I ---